Incruse Ellipta (previously Incruse)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

umeclidinium bromide

Saatavilla:

GlaxoSmithKline (Ireland) Limited

ATC-koodi:

R03BB07

INN (Kansainvälinen yleisnimi):

umeclidinium bromide

Terapeuttinen ryhmä:

Drugs for obstructive airway diseases,

Terapeuttinen alue:

Pulmonary Disease, Chronic Obstructive

Käyttöaiheet:

Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).,

Tuoteyhteenveto:

Revision: 18

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-04-28

Pakkausseloste

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INCRUSE ELLIPTA 55 MICROGRAMS INHALATION POWDER, PRE-DISPENSED
umeclidinium
This medicine is subject to additional monitoring. This will allow
quick identification of
new safety information. You can help by reporting any side effects you
may get. See the end of
section 4 for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Incruse Ellipta is and what it is used for
2.
What you need to know before you use Incruse Ellipta
3.
How to use Incruse Ellipta
4.
Possible side effects
5.
How to store Incruse Ellipta
6.
Contents of the pack and other information
Step-by-step instructions for use
1.
WHAT INCRUSE ELLIPTA IS AND WHAT IT IS USED FOR
WHAT INCRUSE ELLIPTA IS
Incruse Ellipta contains the active substance umeclidinium (as
bromide), which belongs to a
group of medicines called bronchodilators.
WHAT INCRUSE ELLIPTA IS USED FOR
This medicine is used to treat chronic obstructive pulmonary disease (
COPD
) in adults. COPD
is a long-term condition in which the airways and air-sacs in the
lungs gradually become
blocked or damaged, leading to breathing difficulties that slowly get
worse. Difficulties in
breathing is added to by tightening of the muscles around the airways,
which narrows the
airways and so restricts the flow of air.
This medicine blocks the tightening of these muscles, making it easier
for air to get in and out of
the lungs. When used regularly, it can help control your breathing
di

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece ) of
55 micrograms umeclidinium (equivalent to 65 micrograms of
umeclidinium bromide). This
corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium
equivalent to
74.2 micrograms umeclidinium bromide.
Excipient with known effect
Each delivered dose contains approximately 12.5 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed (inhalation powder)
White powder in a grey inhaler (Ellipta) with a light green mouthpiece
cover and a dose
counter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Incruse Ellipta is indicated as a maintenance bronchodilator treatment
to relieve symptoms in
adult patients with chronic obstructive pulmonary disease (COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
The recommended dose is one inhalation once daily.
It should be administered each day at the same time of the day to
maintain bronchodilation. The
maximum dose is one inhalation once daily. If a dose is missed the
next dose should be inhaled
at the usual time the next day.
Special populations
_Elderly _
No dose adjustment is required in patients 65 years of age or older
(see section 5.2).
3
_Renal impairment _
_ _
No dose adjustment is required in patients with renal impairment (see
section 5.2).
_Hepatic impairment _
_ _
No dose adjustment is required in patients with mild or moderate
hepatic impairment.
Umeclidinium has not been studied in patients with severe hepatic
impairment and should be
used with cauti